Gastric CancerPhase 2NCT00857246
Pre-operation Chemo and Antibody Therapy Followed by Surgical Resection and Adjuvant Chemoradiation for Gastric Cancer
A Phase 2 study testing Cetuximab, Irinotecan and Cisplatin in people with Gastric Cancer and Stomach Cancer, run by NYU Langone Health at 1 site in United States.
Trial summary
This study intends to evaluate the feasibility and treatment efficacy of adding an antibody blocking the epidermal growth factor (EGF) pathway to a neoadjuvant approach with proven efficacy developed at New York University. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer, Stomach Cancer
- What is being tested?
- Cetuximab, Irinotecan and Cisplatin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to Oct 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have signed an approved informed consent.
- must have histologically documented untreated gastric/GEJ carcinoma (clinical stage T3 N0 or T4, or any T with N1-N3 M0)
- Patients with tumor tissue available for assessment of EGF receptor status by immuno-histochemistry (IHC).
- Patients with Performance Status 0-2.
- Patients, 18 years and older, must either be not of child bearing potential or have a negative pregnancy test within 7 days of treatment. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal.
- Bone marrow function: absolute neutrophil count (ANC) at least 1,500/ul; platelets at least 100,000/ul.
Show all 9Show fewer
- Renal function: creatinine not greater than 1.5 x institutional upper limit of normal (ULN).
- The PT and PTT should be within the range of normal values
- Hepatic function: bilirubin not greater than 1.5 x ULN; aspartate aminotransferase (AST) not greater than 2.5 x ULN.
Who cannot join
- Acute hepatitis or known HIV.
- Active or uncontrolled infection.
- Significant history of uncontrolled cardiac disease; i.e., uncontrolled hypertension, unstable angina, and congestive heart failure.
- Prior therapy that affects or targets the EGF pathway.
- Prior allergic reaction to chimerized or murine monoclonal antibody therapy or documented presence of human anti-mouse antibodies (HAMA).
- Any concurrent chemotherapy not indicated in the study protocol or any other investigational agent(s).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neoadjuvant Therapy of Gastric Cancer With Irinotecan, Cisplatin and Cetuximab Followed by Surgical Resection and Adjuvant Chemoradiation
This study intends to evaluate the feasibility and treatment efficacy of adding an antibody blocking the epidermal growth factor (EGF) pathway to a neoadjuvant approach with proven efficacy developed at New York University.
Read the detailed description
The overall objective of this study is the development of definitive treatments for patients with locally advanced gastric cancer. To this end, this trial is evaluating the feasibility and treatment efficacy of adding an antibody blocking the EGF pathway to a neoadjuvant approach with proven efficacy developed at New York University (NYU). The combination of Irinotecan and Cisplatin has been shown to be synergistic and active against gastric carcinoma. This trial therefore builds upon NYU previous experience with the neoadjuvant administration of Irinotecan combined with Cisplatin as well as the reported enhanced activity of Irinotecan, Cisplatin and External beam radiation when combined with Cetuximab to develop a novel neoadjuvant and adjuvant approach for the treatment of gastric and gastro-esophageal junction (GEJ) cancers. The program includes: 1) systemic combination of Irinotecan, Cisplatin and Cetuximab used as an induction, 2) followed by potentially curative gastrectomy or GEJ resection, and 3) post-operative chemoradiation as reported in the Intergroup study with the addition of Cetuximab.
- Conditions
- Gastric Cancer, Stomach Cancer
- Being tested
- Cetuximab, Irinotecan, Cisplatin, Surgery, 5-FU
- Keywords
- stomach cancer, biologics, antibody, chemotherapy, chemoradiation, adjuvant therapy, neoadjuvant therapy, epidermal growth factor receptor, combination therapy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetuximabDrug
Also called Erbitux
IrinotecanDrug
Also called CPT-11, Camptosar
CisplatinDrug
Also called Platinol-AQ
SurgeryProcedure or surgery
5-FUDrug
Also called Fluorourocil
RadiationRadiation
| Study group | Role | What they receive |
|---|---|---|
| Induction/ surgery/ chemoRT | Experimental | 1. Induction treatment (3 weeks/cycle x 4 cycles): Cisplatin and Irinotecan on days 1 and 8; Cetuximab on days 1, 8, and 15.
2. Surgery (starts 3-4 weeks after induction treatment).
3. Chemoradiation treatment (starts 4-6 weeks after surgery):
weeks 1-19: Cetuximab on day 1 of every week; week 1: 5-FU and Leucovorin (LV) x 5 days; weeks 2-4: recovery; weeks 5-9: radiation, 150 cGy x 5 fractions/week x 5 weeks; week 5: 5-FU+ LV on days 1-4; week 9: 5-FU+ LV on days 1-3; weeks 14 and 19: 5-FU+LV x 5days Receives: Drug: Cetuximab; Drug: Irinotecan; Drug: Cisplatin; Procedure: Surgery; Drug: 5-FU; Radiation: Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Response Rate of an Induction Regimen Consisting of Irinotecan, Cisplatin and Cetuximab
Clinical response rate is defined as the percentage of patients who responded to the induction regimen. The response is determined based on endoscopic ultrasonography (EUS) staging pre-treatment and post-treatment, CT scans pre- and post- operatively, and initial clinical stage (based on these tests) compared with the pathologic stage. Any "down-staging" of T or N stage is considered to be a result of induction therapy and counted as a clinical response.
Measured: 4 months from the beginning of the induction regimen
Secondary outcomes (6)
Rate of Clearance of Nodal Involvement Among Patients Who Have Received the Induction Therapy
This is defined as the percentage of patients whose nodal involvement of cancer has been cleared based on surgery results.
Measured: 4 months from the beginning of the induction treatment
Rate of Potentially Curative Surgery
This is defined as the percentage of patients who underwent curative surgery (surgery to remove all cancerous tissue).
Measured: 4 months from the beginning of the induction treatment
Rate of "Down-staging" From Pre-operative Clinical Staging
This is defined as the percentage of patients who had a reduction from T3/T4 disease.
Measured: 4 months from the beginning of the induction treatment
Safety of the Induction Regimen
This describes the number of patients who experienced grade 3 and higher adverse events related to the regimen.
Measured: 4 months from the beginning of the induction
Median Overall Survival (Induction Treatment and Curative Surgery)
This is the length of time from the start of treatment that half of the patients are still alive.
Measured: up to 5 years
Median Overall Survival (Adjuvant Therpary)
This is the length of time from the start of treatment that half of the patients are still alive.
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2009 (estimated)
- Study startJul 2005
- Primary completionSep 2011
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb, Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- Theresa Ryan, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00857246
- Sponsor's protocol ID
- 04-72 (H12637)
- Other IDs
- BMS #CA225112
- Status last verified
- Nov 2015
- First submitted
- 4 Mar 2009
- Last updated
- 7 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Therapy of Gastric Cancer With Irinotecan, Cisplatin and Cetuximab Followed by Surgical Resection and Adjuvant Chemoradiation
- ClinicalTrials.gov ID
- NCT00857246
- Acronym / sponsor ID
- 04-72 (H12637)
- Conditions
- Gastric Cancer, Stomach Cancer
- Keywords
- stomach cancer, biologics, antibody, chemotherapy, chemoradiation, adjuvant therapy, neoadjuvant therapy, epidermal growth factor receptor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb, Eli Lilly and Company
- Study start
- Jul 2005
- Primary completion
- Sep 2011 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 6 Mar 2009 (estimated)
- Results
- Posted 13 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study intends to evaluate the feasibility and treatment efficacy of adding an antibody blocking the epidermal growth factor (EGF) pathway to a neoadjuvant approach with proven efficacy developed at New York University.
Detailed description
The overall objective of this study is the development of definitive treatments for patients with locally advanced gastric cancer. To this end, this trial is evaluating the feasibility and treatment efficacy of adding an antibody blocking the EGF pathway to a neoadjuvant approach with proven efficacy developed at New York University (NYU). The combination of Irinotecan and Cisplatin has been shown to be synergistic and active against gastric carcinoma. This trial therefore builds upon NYU previous experience with the neoadjuvant administration of Irinotecan combined with Cisplatin as well as the reported enhanced activity of Irinotecan, Cisplatin and External beam radiation when combined with Cetuximab to develop a novel neoadjuvant and adjuvant approach for the treatment of gastric and gastro-esophageal junction (GEJ) cancers. The program includes: 1) systemic combination of Irinotecan, Cisplatin and Cetuximab used as an induction, 2) followed by potentially curative gastrectomy or GEJ resection, and 3) post-operative chemoradiation as reported in the Intergroup study with the addition of Cetuximab.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Induction/ surgery/ chemoRT | Experimental | Drug: Cetuximab, Drug: Irinotecan, Drug: Cisplatin, Procedure: Surgery, Drug: 5-FU, Radiation: Radiation1. Induction treatment (3 weeks/cycle x 4 cycles): Cisplatin and Irinotecan on days 1 and 8; Cetuximab on days 1, 8, and 15. 2. Surgery (starts 3-4 weeks after induction treatment). 3. Chemoradiation treatment (starts 4-6 weeks after surgery): weeks 1-19: Cetuximab on day 1 of every week; week 1: 5-FU and Leucovorin (LV) x 5 days; weeks 2-4: recovery; weeks 5-9: radiation, 150 cGy x 5 fractions/week x 5 weeks; week 5: 5-FU+ LV on days 1-4; week 9: 5-FU+ LV on days 1-3; weeks 14 and 19: 5-FU+LV x 5days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients must have signed an approved informed consent.
- must have histologically documented untreated gastric/GEJ carcinoma (clinical stage T3 N0 or T4, or any T with N1-N3 M0)
- Patients with tumor tissue available for assessment of EGF receptor status by immuno-histochemistry (IHC).
- Patients with Performance Status 0-2.
- Patients, 18 years and older, must either be not of child bearing potential or have a negative pregnancy test within 7 days of treatment. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal.
Key exclusion criteria (6 listed)
- Acute hepatitis or known HIV.
- Active or uncontrolled infection.
- Significant history of uncontrolled cardiac disease; i.e., uncontrolled hypertension, unstable angina, and congestive heart failure.
- Prior therapy that affects or targets the EGF pathway.
- Prior allergic reaction to chimerized or murine monoclonal antibody therapy or documented presence of human anti-mouse antibodies (HAMA).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CetuximabAlso: Erbitux | Drug | Induction/ surgery/ chemoRT |
| IrinotecanAlso: CPT-11, Camptosar | Drug | Induction/ surgery/ chemoRT |
| CisplatinAlso: Platinol-AQ | Drug | Induction/ surgery/ chemoRT |
| Surgery | Procedure or surgery | Induction/ surgery/ chemoRT |
| 5-FUAlso: Fluorourocil | Drug | Induction/ surgery/ chemoRT |
| Radiation | Radiation | Induction/ surgery/ chemoRT |
Primary outcome
Clinical Response Rate of an Induction Regimen Consisting of Irinotecan, Cisplatin and Cetuximab
Time frame: 4 months from the beginning of the induction regimen
Clinical response rate is defined as the percentage of patients who responded to the induction regimen. The response is determined based on endoscopic ultrasonography (EUS) staging pre-treatment and post-treatment, CT scans pre- and post- operatively, and initial clinical stage (based on these tests) compared with the pathologic stage. Any "down-staging" of T or N stage is considered to be a result of induction therapy and counted as a clinical response.
6 secondary outcomes
Rate of Clearance of Nodal Involvement Among Patients Who Have Received the Induction Therapy
Time frame: 4 months from the beginning of the induction treatment
Rate of Potentially Curative Surgery
Time frame: 4 months from the beginning of the induction treatment
Rate of "Down-staging" From Pre-operative Clinical Staging
Time frame: 4 months from the beginning of the induction treatment
Safety of the Induction Regimen
Time frame: 4 months from the beginning of the induction
Median Overall Survival (Induction Treatment and Curative Surgery)
Time frame: up to 5 years
Median Overall Survival (Adjuvant Therpary)
Time frame: up to 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Gastric Cancer
RecruitingObservational study
Obtaining Solid Tumor Tissue From People Having Biopsy or Surgery for Certain Types of Cancer
Colorectal Neoplasms, Gastric Neoplasms
RecruitingPhase 1
A Study of LY4257496 in Participants With Cancer (OMNIRAY)
Breast Neoplasms, Colorectal Neoplasms
Active, not recruitingPhase 2
Efficacy and Safety of Serplulimab Combined With Chemotherapy as Neoadjuvant Treatment for Locally Advanced Gastric Cancer or Adenocarcinoma of Esophagogastric Junction
Stomach Neoplasms, Immune Checkpoint Inhibitors
Active, not recruitingPhase 1
A Study of KK2269 in Adult Participants With Solid Tumors
Advanced Solid Tumor, Metastatic Solid Tumor
RecruitingPhase 1/2
A Study to Evaluate the Efficacy and Safety of Ifinatamab Deruxtecan (I-DXd) in Subjects With Recurrent or Metastatic Solid Tumors (IDeate-PanTumor02)
Recurrent or Metastatic Solid Tumors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theresa Ryan, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cetuximab, Irinotecan and Cisplatin in people with Gastric Cancer and Stomach Cancer, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Response Rate of an Induction Regimen Consisting of Irinotecan, Cisplatin and Cetuximab (time frame: 4 months from the beginning of the induction regimen). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2015.